There are very large numbers of variables that influence the overall yield of product in a biological synthetic process, for example the host organism selected, the genetic modifications of the host and physical factors such as medium composition, temperature, pH and oxygen availability. The question of how to design the most efficient process given the influence of so many variable factors is therefore one of searching a very high dimensional space for areas of maximal reproducible yield of the required output such as a product. A common approach in the art is to optimise one factor at a time—the combinatorial increase in complexity of investigating increasing numbers of factors simultaneously is seemingly an insurmountable barrier to many researchers. Although this approach has the appeal of conceptual simplicity and may be taught as good experimental practice it is a highly inefficient bioprocess optimization strategy since biological systems are inherently multi-factorial in nature. Consequently, manufacturing processes that require the use of live organisms, enzymes or cellular extracts developed using the one factor at a time approach frequently suffer from issues such as unacceptable levels of batch-to-batch variability, poor product yields or both. These characteristics are not suitable for quality manufacturing processes and represent a considerable barrier to those wishing to utilise bioprocessing steps in manufacturing systems.
Despite these problems many successful bioprocesses have been developed and there is a recognised potential for bio-based manufacturing to provide enormous benefits across many areas. To overcome this problem requires the adoption of multifactorial methods to identify key sources of process variability and identify higher process yields, thereby substantially de-risking bioprocess development. To achieve this, there exists a need in the art to provide methods and systems that can facilitate reliable design of experiments from the level of the lab bench up to and including the industrial-scale bioreactor. These and other uses, features and advantages of the invention should be apparent to those skilled in the art from the teachings provided herein.